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Tailoring the Patent System for Specific
Industries
John R. Thomas
Visiting Scholar
October 29, 2013
Congressional Research Service
7-5700
www.crs.gov
R43264
CRS Report for Congress
Pr
epared for Members and Committees of Congress
c11173008
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Tailoring the Patent System for Specific Industries
Summary
Congressional interest in the patent system has been demonstrated by the enactment of the Leahy-
Smith America Invents Act (AIA) in the 112th Congress. Most of the provisions of the AIA apply
to any type of patented invention, whether it consists of a chemical compound, mechanical
device, electrical circuit, or other technology. However, other AIA provisions are specific to
particular types of inventions, including business methods, tax strategies, and human organisms.
The AIA reflects the principle that, for the most part, patentable inventions are generally subject
to the same statutory provisions. However, a number of exceptions exist to this concept of
technological neutrality.
This blended architecture has for many years prompted inquiry into whether the patent system
operates best as a uniform system that applies neutrally to all inventions, or whether it could or
should be tailored to meet the specific needs of different industries. Technologies and industrial
sectors arguably differ in ways salient to the patent system. Among these distinctions are the costs
and risks of research and development, the availability of trade secret protection as an effective
alternative to patenting, the number of patents that cover a particular product, and the patterns of
patent acquisition and enforcement of firms within that sector. The patent system involves a
number of parameters that could potentially be adjusted to meet the needs of individual sectors,
including the speed with which applications are reviewed, the scope of exclusive rights afforded
by a patent, and the term of the patent.
While some observers suggest the desirability of sector-specific patent principles, others believe
them to be infeasible and unwise. They observe that legislative efforts to define particular
industries may prove difficult, that attorneys may sometimes be able to draft patents artfully so as
to fall within a favored category, and that U.S. industry is dynamic and resistive to a static
statutory definition. In addition, U.S. membership within the World Trade Organization (WTO)
may limit the ability to tailor the patent system to account for different industries and inventions,
to the extent that compliance with WTO standards is desired. The WTO-administered Agreement
on Trade-Related Aspects of Intellectual Property, or TRIPS Agreement, in part requires WTO
member states to make patent rights available without discrimination as to the field of technology.
The TRIPS Agreement admits some exceptions exist to this principle of technological neutrality,
however.
Should Congress believe current circumstances to be appropriate, then no action need be taken.
To the degree WTO compliance is desired, Congress could also legislate along the lines permitted
by the TRIPS Agreement. Notably, although the TRIPS Agreement generally disallows
discrimination with respect to technological fields, it permits distinctions on other grounds.
Congress could also make use of regulatory exclusivities and other complementary intellectual
property rights that the TRIPS Agreement regulates less heavily.
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Contents
Introduction ...................................................................................................................................... 1
Patent Fundamentals ........................................................................................................................ 2
The Role of Patents Within Different Industries .............................................................................. 4
Implications for the Patent System .................................................................................................. 5
The Feasibility of Sector-Specific Patent Rules .............................................................................. 9
Concluding Observations ............................................................................................................... 12
Contacts
Author Contact Information........................................................................................................... 13
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Introduction
The recent enactment of the Leahy-Smith America Invents Act (AIA)1 demonstrates
congressional interest in the patent system. Most of the provisions of the AIA apply to any type of
patented invention. For example, the first-inventor-to-file priority system,2 prior user rights,3 and
post-grant and inter partes review proceedings4 apply equally to chemical compounds, electrical
appliances, mechanical devices, and any other invention that may be protected by a patent.
However, other AIA provisions are specific to particular types of inventions. That statute limited
the availability of patents on tax strategies,5 prohibits the issuance of patents claiming human
organisms,6 and creates “transitional proceedings” that apply exclusively to patents pertaining to
business methods.7 The AIA also allows “prioritization of examination of applications for
products, processes, or technologies that are important to the national economy or national
competitiveness.... ”8
The AIA reflects the principle that, for the most part, the U.S. patent system operates in a uniform
manner. All patentable inventions are generally subject to the same statutory provisions.9 A
number of exceptions exist to this concept of technological neutrality, however. For example,
statutory provisions limit the enforceability of patents claiming methods of medical treatment;10
call for patent term extension for certain products regulated by the Food and Drug Administration
(FDA);11 and establish specialized patents for designs and plants.12
This blended architecture has for many years prompted inquiry into whether the patent system
operates best as a uniform system that applies neutrally to all inventions, or whether it could or
should be tailored to meet the specific needs of different industries.13 Commentators have
proposed, for example, that software patents should receive shorter terms than patents on other
inventions,14 and that patents on genes should be subject to compulsory licenses that allow
individuals to use the patented technology upon paying a license fee.15 Unenacted legislation in
1 P.L. 112-29, 125 Stat. 284 (2011). See CRS Report R42014, The Leahy-Smith America Invents Act: Innovation
Issues, by Wendy H. Schacht and John R. Thomas.
2 Ibid. at § 3.
3 Ibid. at § 5.
4 Ibid. at § 6.
5 Ibid. at § 14.
6 Ibid. at § 33.
7 Ibid. at § 18.
8 Ibid. at § 25.
9 Clarisa Long, “Our Uniform Patent System,” 55 The Federal Lawyer (2008), 44.
10 35 U.S.C. § 287(c).
11 35 U.S.C. § 156.
12 35 U.S.C. §§ 161, 171.
13 Michael W. Carroll, “One Size Does Not Fit All: A Framework for Tailoring Intellectual Property Rights,” 70 Ohio
State Law Journal (2009), 1361.
14 Mark H. Webbink, “A New Paradigm for Intellectual Property Rights in Software,” Duke Law & Technology Review
(2005), 12.
15 Daniel M. Lorentzen, “Do These Genes Fit? Genes as Patentable Subject Matter,” 60 Drake Law Review (2012),
933.
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the 112th Congress, H.R. 6245, proposed patent litigation reforms that would apply to patents
claiming computer software and hardware, but not to other sorts of inventions.
Notably, U.S. membership in the World Trade Organization (WTO) may influence congressional
willingness to promulgate industry-specific patent statutes. One component of the WTO
agreements, the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS
Agreement),16 requires patents to be available and enforceable “without discrimination as to ... the
field of technology....”17 Although the TRIPS Agreement allows for some limited exceptions to
this rule of technological neutrality,18 one consequence of U.S. membership in the WTO may be a
restricted ability to tailor the patent statute to particular inventions and industries.19
This report considers the possibility of modifying the U.S. patent system to meet the needs of
specific industries. After providing a brief review of the patent system, the report identifies
different industrial traits, such as the pace of innovation, product cycle, and the cost of research
and development, which potentially suggest the desirability of tailored patent rights. It then
considers possible points of adjustment within the patent system, including patent term, scope of
exclusive rights, and the availability of remedies for infringement. The report then discusses
potential difficulties associated with distinguishing among industries within the patent system,
including the provisions of the TRIPS Agreement. The report closes with concluding
observations.
Patent Fundamentals
The patent system covers a broad variety of inventions.20 U.S. patents cover traditional subject
matter such as machines, pharmaceuticals, and manufacturing processes, along with high-tech
inventions in the fields of biotechnology, computer software, and nanotechnology. No matter
what the sort of technology, however, the patent system in large measure operates under the same
general principles.
In particular, all inventors who wish to obtain patent rights must file an application at the U.S.
Patent and Trademark Office (USPTO). USPTO examiners then review the application to ensure
that certain statutory requirements are met. These statutory requirements—including that the
invention be adequately described in the patent application,21 and that the invention must not have
been obvious to a skilled artisan22—apply to every invention for which a patent is sought.
Similarly, once a patent has issued, the statutory term is set uniformly to 20 years from the date of
filing no matter what the type of invention.23 All patents received the identical exclusive rights—
16 Agreement on Trade-Related Aspects of Intellectual Property Rights, April 15, 1994, Marrakesh Agreement
Establishing the World Trade Organization, Annex 1C, 1869 U.N.T.S. 299 (1994).
17 Ibid. at Art. 27.
18 Ibid.
19 Dan L. Burk & Mark A. Lemley, “Is Patent Law Technology-Specific?,” 17 Berkeley Technology Law Journal
(2002) 1155.
20 35 U.S.C. § 101 (patents available on machines, manufactures, compositions of matter, and processes).
21 35 U.S.C. § 112(a).
22 35 U.S.C. § 103.
23 35 U.S.C. § 154(a)(2).
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namely, the right to prevent others from making, using, selling, offering to sell, or importing the
patented invention in the United States.24
Some exceptions exist to this general notion of standardization. The United States has long
provided for the protection of industrial designs through so-called “design patents.”25 The Patent
Law Treaties Implementation Act of 2012, P.L. 112-211, recently caused U.S. law to conform to
the Hague Agreement Concerning the International Registration of Industrial Designs, the leading
international agreement on these specialized rights. The United States also established two sorts
of intellectual property rights for plants: plant patents, which are administered by the USPTO;26
and plant variety protection certificates, which are administered by the Department of
Agriculture.27 In addition, the Hatch-Waxman Act extends the terms of patents covering
pharmaceuticals, medical devices, and other products which are subject to premarketing approval
by the FDA.28 As well, over the years private legislation has increased the terms of a number of
particular patents.29
Further, some commentators observe that the statutory provisions for patents are stated fairly
generally. In their view, these broad parameters provide courts and the USPTO with some ability
to recognize the diverse characteristics of distinct technologies and tailor their rulings
accordingly.30 For example, one core patentability requirement is that the invention must not have
been obvious to a person of ordinary skill in the art.31 The courts have arguably developed
nuanced obviousness principles that take into account whether the invention falls within a
predictable art, including many mechanical and electrical inventions, as compared to a less
predictable art, such as some branches of chemistry and biotechnology. Inventions within these
latter, less predictable arts may possibly be more readily able to satisfy the obviousness
requirement and therefore are more likely to be patented.32
Despite these exceptions, the Patent Act of 1952, as amended by such legislation as the American
Inventors Protection Act33 and AIA, is generally worded in a neutral fashion.34 The uniform
treatment provided by the patent system may be contrasted with the diversity of the technologies
and industries to which patents pertain, however, a topic this report takes up next.
24 35 U.S.C. § 271(a).
25 35 U.S.C. § 171-173.
26 35 U.S.C. §§ 161-164.
27 7 U.S.C. §§ 2321-2582.
28 35 U.S.C. § 156. See CRS Report R41114, The Hatch-Waxman Act: Over a Quarter Century Later, by Wendy H.
Schacht and John R. Thomas.
29 See CRS Report RS21129, Pharmaceutical Patent Term Extensions: A Brief Explanation, by Wendy H. Schacht and
John R. Thomas.
30 Dan L. Burk and Mark A. Lemley, “Policy Levers in Patent Law,” 89 Virginia Law Review (2003), 1575.
31 35 U.S.C. § 103(a).
32 See Briana Barron, “Structural Uncertainty: Understanding the Federal Circuit’s Lead Compound Analysis,” 16
Marquette Intellectual Property Law Review (Summer 2012), 401.
33 P.L. 106-113.
34 Michael W. Carroll, “One for All: The Problem of Uniformity Cost in Intellectual Property Law,” 55 American
University Law Review (2006), 845.
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The Role of Patents Within Different Industries
Commentators have for many years recognized that technologies and industries vary in ways that
are salient to the patent system. In particular, the costs and risks of conducting R&D differ widely
among industries. Arguably the patent incentive should be greater for innovative efforts that are
expensive and more likely to fail.35 Similarly, some sectors are marked by stand-alone, discrete
advances, while others feature steady, cumulative innovation. Firms that operate within the latter
sorts of industries may have greater need to access technologies invented and patented by
others.36
As well, product cycles also vary markedly across the U.S. economy. For example, patients may
use a particular pharmaceutical for decades, even as consumers quickly discard their old mobile
telephones and other electronics in favor of new devices. Industries with compact product cycles
may be better served by short application pendency periods at the USPTO and also may be less
concerned with lengthy terms of patent protection.37
Still another factor may be the practical availability of trade secret protection.38 Competitors may
readily reverse engineer many electrical and mechanical products, for example. Firms within
these industries must therefore seek patent rights or enjoy no effective intellectual property rights
whatsoever. On the other hand, certain chemical and biotechnology inventions may be more
plausibly maintained as trade secrets. Arguably greater encouragement is needed for public
disclosure of chemical and biological inventions through the patent system.39
The number of patents that cover a particular product also varies widely among industry. Within
the pharmaceutical industry, often only a handful, and sometimes only one or two patents cover
an individual drug. In contrast, numerous patents may cover a particular electronics product. As
RPX Corporation, a self-described “comprehensive patent risk management firm,” explains:
Modern products and services incorporate numerous technology components. The evolution
of mobile devices provides an example. Based on our research, we believe there are more
than 250,000 active patents relevant to today’s smartphones, a significant increase compared
to our estimate of approximately 70,000 patents that were active and relevant to mobile
phones in 2000. This growth can be attributed to the expanded set of features and
functionality incorporated in today’s smartphones, including touchscreens, internet access,
streaming video, media playback, application store readiness and other web-based services,
and WiFi connectivity options.40
35 For discussion of how the features of a patent system might pertain to R&D costs, see Robert M. Hunt, “Economics
and the Design of Patent Systems,” 13 Michigan Telecommunications & Technology Law Review (Spring 2007), 457.
36 See Mark A. Lemley, “The Myth of the Sole Inventor,” 110 Michigan Law Review (2012), 709 (discussing how
cumulative innovation witnessed in many industries may impact patent law principles).
37 See Sarah A. Geers, “Common Sense and the Fact Finder Without Skill in the Art: The Role of Objective Evidence
in Achieving Proper Technology Specificity,” 40 Seton Hall Law Review (2010), 425 (discussing patent system design
in relation to distinct industry product cycles).
38 See CRS Report R41391, The Role of Trade Secrets in Innovation Policy, by John R. Thomas.
39 For a general discussion of the relationship between patents and trade secrets, see J. Jonas Anderson, “Secret
Inventions,” 26 Berkeley Technology Law Journal (2011), 917.
40 See Daniel O’Connor, “One in Six Active U.S. Patents Pertain to the Smartphone,” Disruptive Competition Project
(Oct. 17, 2012) (available at http://www.project-disco.org/intellectual-property/one-in-six-active-u-s-patents-pertain-to-
the-smartphone/).
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These “vast disparities in patent-to-product” ratios may influence the perceptions of different
business enterprises over the value of individual patents as compared to larger portfolios of
intellectual property rights.41
Another arguable distinction among industries is the detectability of patents that are pertinent to
particular products.42 Fields such as small-molecule chemistry employ an internationally
recognized, standardized nomenclature to identify the composition of a particular compound. As a
result, firms within the agricultural, industrial, and pharmaceutical chemical industries may enjoy
some confidence that they will be able to identify patents that are relevant to products they wish
to sell.43 In contrast, fields such as software arguably have yet to develop a standardized
terminology for identifying programs, procedures, algorithms, and other sorts of machine
instructions. The lack of conventions for identifying software inventions potentially impacts the
patent system, arguably making the identification of pertinent patents difficult for firms in the
computer industry.44
Implications for the Patent System
In view of these and possibly other distinctions between technologies and markets, policymakers
may not be particularly confident that a one-size-fits-all patent system ideally encourages
innovation throughout a diverse array of industries.45 Observers have for many years suggested
that the statute distinguish among the varying inventions and industries for which patents are
available. In theory, many aspects of the patent system could be tailored to reflect the needs of
distinct technology sectors. Some possible points of adjustment include:
• The speed with which the USPTO reviews patent applications could be adjusted
to meet the needs of industries with varying product cycles.
• Patents could be more difficult to obtain within some fields than others
depending upon the perceived need of the patent incentive to encourage
innovation.
• Patents on inventions capable of being protected by trade secrets in whole or in
part—for example, biotechnologies or chemical processes—might be required to
have more complete technical disclosures in order to allow others to practice the
invention expeditiously.
• The term of protection could vary among technologies depending upon the pace
of innovation within particular fields.
41 Graeme B. Dinwoodie and Rochelle C. Dreyfuss, “Diversifying Without Discriminating: Complying with the
Mandates of the TRIPS Agreement,” 13 Michigan Telecommunications & Technology Law Review (2007), 445.
42 See James Bessen and Michael J. Meurer, Patent Failure: How Judges, Bureaucrats, and Lawyers Put Innovation at
Risk (Princeton University Press 2008), 46-72.
43 See Christa J. Laser, “A Definite Claim on Claim Indefiniteness: An Empirical Study of Definiteness Cases of the
Past Decade with a Focus on the Federal Circuit and the Insolubly Ambiguous Standard,” 10 Chicago-Kent Journal of
Intellectual Property (2010), 25.
44 Ibid.
45 Dan L. Burk and Mark A. Lemley, “Is Patent Law Technology-Specific?,” 17 Berkeley Technology Law Journal
(2002) 1155.
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• The scope of exclusive rights could be adjusted in order to immunize select
individuals or enterprises—such as physicians or universities—from liability for
patent infringement.
• Compulsory licenses could be made available for categories of patented
inventions perceived to fulfill an important public need—for example, healthcare
or environmental technologies—thereby allowing third parties to use the
invention without the permission of the patent proprietor.
Congress has implemented some of these technology-specific measures. Among other examples,
the Hatch-Waxman Act extends the terms of patents covering pharmaceuticals, medical devices,
and other products which are subject to premarketing approval.46 Congress also imposed
restrictions upon the enforceability of patents claiming medical procedures.47 Specialized patent
rights exist both for industrial designs and plants.48
More recently, the deliberations that led to the enactment of the Leahy-Smith America Invents
Act (AIA)49 again placed focus upon the role of the patent system within different industries. One
topic that focused attention upon these distinctions concerned the award of remedies when firms
or individuals are found to infringe patents. Broadly speaking, the patent law allows courts to
award two sorts of remedies against infringers: (1) injunctions, or court orders requiring an entity
to cease future infringements;50 and (2) damages, consisting of an award of money to compensate
patent proprietors for financial losses suffered due to infringements.51 The legislative history of
the AIA reveals that certain representatives of the pharmaceutical and information technology
sectors often held different views about the state of the law of patent remedies.52
With respect to injunctions, prior to 2006 courts would virtually always enjoin an adjudicated
infringer from future practice of the patented invention. Some observers—particularly those from
the information technology sector—believed that this “automatic injunction” rule was particularly
unfair when the patented invention supported a single function in a multifunctional product, such
as an automobile, smart phone, or computer software.53 They also believed that this rule
encouraged the assertion of patents of dubious quality and offered patent proprietors too much
leverage during licensing and settlement negotiations.54 However, other observers—primarily
from the pharmaceutical sector—asserted that absent the award of an injunction, competitors
would not respect the exclusive rights afforded by a patent.55
46 35 U.S.C. § 156.
47 35 U.S.C. § 287(c).
48 35 U.S.C. §§ 171-173 (designs); 35 U.S.C. §§ 161-164 (plants).
49 P.L. 112-29, 125 Stat. 284 (2011).
50 35 U.S.C. § 283.
51 35 U.S.C. § 284.
52 See CRS Report RL33367, Patent Reform: Issues in the Biomedical and Software Industries, by Wendy H. Schacht.
53 See Lea Shaver, “Illuminating Innovation: From Patent Racing to Patent War,” 69 Washington & Lee Law Review
(2012), 1891.
54 Nicholas P. Chan, “Balancing Judicial Misvaluation and Patent Hold-Up: Some Principles for Considering Injunctive
Relief After Ebay,” 59 UCLA Law Review (2012), 746.
55 Paul M. Schoenhard, “Who Took My IP? Defending the Availability of Injunctive Relief for Patent Owners,” 16
Texas Intellectual Property Law Journal (2008), 187.
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A predecessor, unenacted version of the AIA, the Patent Reform Act of 2005,56 proposed changes
to the principles governing injunctions in patent law. Section 7 of that bill provided that in
deciding whether to issue an injunction or not, “the court shall consider the fairness of the remedy
in light of all the facts and the relevant interests of the parties associated with the invention.”
Perhaps because of the discordant view of different patent stakeholders as to the availability of
injunctions in the patent community, this provision was identified as one of the most controversial
within the bill.57
While debate about congressional action with respect to injunctions in patent law continued, the
Supreme Court issued its decision in eBay Inc. v. MercExchange, L.L.C. in 2006.58 There the
Court unanimously held that an injunction should not automatically issue based on a finding of
patent infringement. Under the eBay ruling, courts must weigh equitable factors traditionally used
to determine if an injunction should issue, including whether the patent proprietor suffered an
irreparable injury; the award of damages would be inadequate to compensate for that injury; that
considering the balance of hardships between the patent owner and infringer, an injunction is
warranted; and that the public interest would not be disserved by a permanent injunction.59
Following the eBay decision, Congress did not include legislative provisions concerning
injunctive relief in the AIA. Some commentators believe that the Supreme Court struck an
appropriate balance by addressing concerns of information technology firms that were concerned
that patent holders would assert their rights after the launch of a commercially successful product
in an effort to extort an unreasonably large royalty using the threat of an injunction; but also
recognized that most often a prevailing patent holder would be awarded an injunction.60 Further,
the early prediction that “the biotech and pharmaceutical industries have little to fear in the post-
eBay world”61 appears to have been correct, for the great majority of judicial decisions declining
the award of a permanent injunction have concerned information technology patents.62
A second, arguably divisive issue between the information technology and pharmaceutical
industries pertains to damages. Marketplace realities often render the determination of an
appropriate damages award a difficult affair in patent litigation. In some cases, the product or
process that is found to infringe may incorporate numerous additional elements beyond the
patented invention. For example, the asserted patent may relate to a single component of a touch
screen display, while the accused product consists of an entire smartphone. In such circumstances,
a court may apply “the entire market value rule,”63 which “permits recovery of damages based
upon the entire apparatus containing several features, where the patent-related feature is the basis
56 H.R. 2795, 109th Congress.
57 George H. Pike, “The Next Step in Patent Reform,” 28 Information Today no. 10 (Nov. 1, 2011), 1.
58 547 U.S. 388 (2006).
59 See Mark P. Gergen et al., “The Supreme Court’s Accidental Revolution: The Test for Permanent Injunctions,” 112
Columbia Law Review (2012), 203.
60 William C. Rooklidge and Alyson G. Barker, “Reform of a Fast-Moving Target: The Development of Patent Law
Since the 2004 National Academies Report,” 91 Journal of the Patent and Trademark Office Society (2009), 153.
61 Michael Beylkin, “Much Ado About Nothing: The Biotech and Pharmaceutical Industries Have Little to Fear in the
Post-eBay World,” 6 Journal of Telecommunications & High Technology Law (2007), 179.
62 See University of Houston Law Center, PatStats: U.S Patent Litigation Statistics (available at
http://www.patstats.org).
63 LaserDynamics, Inc. v. Quanta Computer, Inc., 694 F.3d 51 (Fed. Cir. 2012).
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for consumer demand.”64 On the other hand, if the court determines that the infringing sales were
due to many factors beyond the use of the patented invention, the court may apply principles of
“apportionment” to reach a just measure of damages for infringement.65
Some believe that current damages standards have resulted in the systemic overcompensation of
patent owners.66 Such overcompensation may place unreasonable royalty burdens upon producers
of high technology products, ultimately impeding the process of technological innovation and
dissemination that the patent system is meant to foster. Others believe that current case law
appropriately accounts for apportionment concerns. These observers are concerned that this
reform might overly restrict damages in patent cases, thereby discouraging voluntary licensing
and promoting infringement of patent rights. Limited damage awards for patent infringement
might prevent innovators from realizing the value of their inventive contributions, a principal goal
of the patent system.67
As discussion of damages reform has proceeded before Congress, the courts have also been
active. One of the more notable cases on patent damages principles arose from the efforts of
Lucent Technologies, Inc., to enforce its so-called “Day patent,” which related to a method of
entering information into fields on a computer screen without using a keyboard.68 In 2002, Lucent
brought an infringement suit against computer manufacturer Gateway, Inc., asserting that certain
pre-installed Microsoft software infringed the Day patent. At trial, the jury found the Day patent
not invalid and infringed. Lucent sought damages of $561.9 million based on 8% of Microsoft’s
infringing sales, while Microsoft asserted “that a lump-sum payment of $6.5 million would have
been the correct amount for licensing the protected technology.” The jury then awarded Lucent a
single lump-sum amount of $357.7 million.69
The litigation in Lucent v. Gateway captured the attention of many observers. In a March 3, 2009,
letter addressed to Senator Patrick Leahy, Senator Arlen Specter requested a delay in Senate
action on the pending patent reform bill until the Federal Circuit heard oral argument in the
case.70 Observing a “symbiotic relationship between the judicial and legislative branches with
regard to changes to the patent system,” Senator Specter believed that “oral argument has the
potential to facilitate a compromise or clarify the applicability of damages theories in various
contexts.”71
In its subsequent decision, the Federal Circuit upheld the lower court’s determination that the Day
patent was not invalid and infringed. In the most anticipated portion of the opinion, the appellate
court also struck down the jury’s damages award as not supported by substantial evidence.72
64 State Industries, Inc. v. Mor-Flo Industries, Inc., 883 F.2d 1573 (Fed. Cir. 1989).
65 See LaserDynamics v. Quanta, supra.
66 See Amy L. Landers, “Let the Games Begin: Incentives to Innovation in the New Economy of Intellectual Property
Law,” 46 Santa Clara Law Review (2006), 307.
67 See William C. Rooklidge, “Reform of the Patent Laws: Forging Legislation Addressing Disparate Interests,” 88 Journal
of the Patent and Trademark Office Society (2006), 9.
68 Lucent Technologies, Inc. v. Gateway, Inc., 580 F.3d 1301 (Fed. Cir. 2009).
69 Ibid. at 1308.
70 The letter is available at http://www.fr.com/files/uploads/attachments//patentdamages//03-03-09-Specter-to-PJL-
Patents.pdf.
71 Ibid.
72 580 F.3d at 1335.
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Some commentators have viewed the lengthy opinion as doing much to dampen speculative
damages awards, particularly with respect to patents from the information technology sector.73
Following that opinion, Lucent and Microsoft have reportedly settled the litigation.74 Of broader
interest, Congress also chose not to address damages for patent infringement within the AIA.
The timely issuance of eBay and Lucent v. Gateway may have contributed to congressional belief
that courts were appropriately addressing injunctions and damages, respectively. As a result,
Congress did not endeavor to reconcile the perceived needs of industries with different innovation
and marketplace environments. Another legislative possibility, at least in theory, was to enact
distinct remedial rules for different categories of inventions. This report next explores whether
industry-specific rules are a practical possibility for patent legislation.
The Feasibility of Sector-Specific Patent Rules
In view of the concerns noted above, commentators have gone so far to say that “it has become
increasingly difficult to believe that a one-size-fits-all approach to patent law can survive.”75 To
the extent the current patent system creates a blanket set of rules that apply comparably to distinct
industries, it likely over-encourages innovation in some contexts and under-incentivizes it in
others.76 Further, some observers have asserted that the need of firms to identify and access the
patented inventions of others may differ among industries.77 As a result, the case can be made that
distinct industrial, technological, and market characteristics that exist across the breadth of the
U.S. economy compel industry-specific patent statutes.
However, others have questioned the wisdom and practicality of such line-drawing.78 The
following concerns, among others, have been identified:
• Over its long history, the U.S. patent system has flexibly adapted to new
technologies such as biotechnology and computer software. Legislative adoption
of technology-specific categories may leave unanticipated, cutting-edge
technologies outside the patent system.79
• Defining a specific industry or category of technologies may prove to be a
contested proposition.80
• Over time, new industries may emerge and old industries may consolidate. The
dynamic nature of the U.S. economy suggests greater need for legislative
oversight within a differentiated patent regime.81
73 See Bo Zeng, “Lucent v. Gateway: Putting the “Reasonable” Back into Reasonable Royalties,” 26 Berkeley
Technology Law Journal (2011), 329.
74 “Microsoft and Alcatel-Lucent Settle Patent Dispute,” Computer News Middle East (Jan. 19, 2012).
75 Dreyfuss and Dinwoodie, supra.
76 See Alan Devlin, “Patent Law’s Parsimony Principle,” 25 Berkeley Technology Law Journal (2010), 1693.
77 See Alan Devlin, “Systematic Bias in Patent Law,” 61 DePaul Law Review (2011), 57.
78 See Luigi Orsenigo and Valerio Sterzi, Comparative Study of the Use of Patents in Different Industries, Knowledge,
Internationalization and Technologies Studies Working Paper 33/2010 (2010).
79 Ibid.
80 See Lewis Kaplow, “Why (Ever) Define Markets?,” 124 Harvard Law Review (2010), 437.
81 Burk and Lemley, supra.
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• Even if an industry or technology remains relatively stable, the innovation
environment within it might change. For example, technological or scientific
advances might open new possibilities for research and development within
hidebound industries—but also increase expense and risk for those firms.82
• Distinct patent rights among industries or technologies may lead to strategic
behavior on behalf of patent applicants. For example, a computer program that
controls a fuel injector within an automobile could possibly be identified as either
an automobile-related or a computer-related invention.83
• The legislative effort to enact sector-specific patent laws may provide an
opportunity for politically savvy firms to exert more lobbying and political
power, at the possible expense of less sophisticated firms.84
In addition to these practical concerns, U.S. membership in the World Trade Organization (WTO)
may restrict congressional ability to tailor the patent system to account for different industries and
inventions, to the extent that compliance with WTO standards is desired. The Agreement on
Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) is a WTO-
administered treaty that stipulates minimum standards for many forms of intellectual property
protection.85 Article 27, paragraph one of the TRIPS Agreement expressly provides that, with
some exceptions, “patents shall be available and patent rights enjoyable without discrimination as
to the place of invention, the field of technology and whether products are imported or locally
produced.”
At the time it was drafted, the TRIPS Agreement standard of technological neutrality was
arguably intended to provide for patent protection for a variety of inventions for which patents
were previously unavailable in many countries.86 For example, certain jurisdictions did not allow
patents to issue on pharmaceuticals and agricultural chemicals prior to joining the WTO. The
wording of Article 27.1 appears to have broader implications than merely requiring WTO
member states to grant patents on pharmaceuticals and other previously unpatentable inventions,
however. Its principle of nondiscrimination seems broadly to require that all inventions in all
fields of technology be treated identically—a reading that would block, for example,
discriminating in favor of particular inventions as well as against them.87
Article 27 expressly permits some limited exceptions to this concept of homogeneity. In
particular, WTO members may exclude from patentability inventions whose commercial
exploitation would violate the public order or morality. However, inventions may not be
exempted from patentability merely because their use is illegal.88 In addition, diagnostic,
82 Orsenigo and Sterzi, supra.
83 See Kristen Osenga, “The Shape of Things to Come: What We Can Learn About Patent Claim Length,” 28 Santa
Clara Computer & High Technology Law Journal (2012), 617.
84 Burk and Lemley, supra.
85 Agreement on Trade-Related Aspects of Intellectual Property Rights, Apr. 15, 1994, Marrakesh Agreement
Establishing the World Trade Organization, Annex 1C, 1869 U.N.T.S. 299, 33 I.L.M. 1197 (1994).
86 See Robert Weissman, “A Long, Strange Trips: The Pharmaceutical Industry Drive to Harmonize Global Intellectual
Property Rules, and the Remaining WTO Legal Alternatives Available to Third World Countries,” 17 University of
Pennsylvania Journal of International Economic Law (1996), 1069.
87 See Rebecca S. Eisenberg, “The Role of the FDA in Innovation Policy,” 13 Michigan Telecommunications &
Technology Law Review (2007), 345.
88 TRIPS Art. 27.2.
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therapeutic, and surgical methods may also be excluded from patentability.89 In addition, WTO
member states may deny patents on “plants and animals other than micro-organisms, and
essentially biological processes for the production of plants or animals other than non-biological
and microbiological processes.” However, if a WTO member state opts to do so, it must protect
plant varieties through an alternative specialized system, typically known as “plant breeder’s
rights.”90 In addition, the TRIPS Agreement allows for “security exceptions” that permit WTO
members to take any action considered necessary for the protection of “essential security
interests.”91
In addition, Article 30 of the TRIPS Agreement allows for “exceptions to rights conferred.” The
TRIPS Agreement stipulates that each WTO member state must provide patent proprietors with
the right to exclude others from making, using, selling, offering to sell, and importing the
patented invention.92 Article 30 then reads:
Members may provide limited exceptions to the exclusive rights conferred by a patent,
provided that such exceptions do not unreasonably conflict with a normal exploitation of the
patent and do not unreasonably prejudice the legitimate interests of the patent owner, taking
account of the legitimate interests of third parties.
Article 30 appears to contemplate limited exceptions to the patent rights for such reasons as
scientific experiments or use of a patented product for purposes of obtaining regulatory
approval.93
At first glance, Article 30 of the TRIPS Agreement might seem to provide WTO member states
with the ability to provide technology-specific exceptions despite the wording of Article 27.1.
However, one dispute settlement panel of the WTO has “concluded ... that the anti-discrimination
rule of Article 27.1 does apply to exceptions of the kind authorized by Article 30.”94 Stated
differently, the WTO has reasoned that even exceptions to a patent owner’s exclusive rights must
be technology neutral.
The WTO’s conclusion that even exceptions to a patent holder’s exclusive rights must operate in
a uniform manner has attracted some critical commentary. On one hand, if an exception to a
patent holder’s exclusive rights must apply to all technologies and industries, it is less likely to be
“limited” and therefore compatible with Article 27.1.95 On the other hand, the WTO reasoned that
“the TRIPS Agreement [required] governments to apply exceptions in a nondiscriminatory
manner, in order to ensure that governments do not succumb to domestic pressures to limit
exceptions to areas where right holders tend to be foreign producers.”96
89 Ibid. at Art. 27.3(a).
90 Ibid. at Art. 27.3(b).
91 Ibid. at Art. 73.
92 Ibid. at Art. 28.
93 See Scott Taylor, “Where Are the Green Machines? Using the Patent System to Encourage Green Invention and
Technology Transfer,” 23 Georgetown International Environmental Law Review (2011), 577.
94 Panel Report, Canada-Patent Protection of Pharmaceutical Products, WT/DS114/R (Mar. 17, 2000) [hereinafter
“Canada Pharmaceutical”].
95 See Dinwoodie and Dreyfuss, supra.
96 Canada Pharmaceutical, paragraph 7.92.
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The WTO dispute resolution panel in the Canada Pharmaceutical case further observed:
[I]t is not true that Article 27 requires all Article 30 exceptions to be applied to all products.
Article 27 prohibits only discrimination as to the place of invention, the field of technology,
and whether products are imported or produced locally. Article 27 does not prohibit bona
fide exceptions to deal with problems that may exist only in certain product areas.97
The distinction drawn by the WTO panel between the terms “field of technology” and “certain
product areas” arguably does not shimmer with clarity. The panel’s opinion obtains no further
guidance as to the meaning of “certain product areas.” However, some commentators have
suggested that patent statutes may permissibly draw distinctions based on narrow categories of
goods or services, in contrast to broader fields of technological endeavor. For example, Wesley A.
Cann, Jr., an emeritus member of the University of Connecticut business school faculty, has
asserted that “[e]ven if Article 30 would not allow a limited exception to be directed at the entire
pharmaceutical industry (a position that is still open to substantial doubt), it can be argued that an
exception could be made for those particular pharmaceuticals aimed at the prevention and
treatment of HIV/AIDS.”98
As a result, the membership of the United States within the WTO provides a possible constraint
against tailoring the patent system to meet the perceived needs of specific industries. To the
extent that WTO compliance is desired, the U.S. patent system must ordinarily act in a
homogenous manner with respect to particular fields of technology. The TRIPS Agreement does
permit some specific exceptions, however, for such subject matter as diagnostic, therapeutic, and
surgical methods; matters of national security; and, as explained by the Canada Pharmaceutical
WTO panel, “certain product areas.”
Concluding Observations
The patent system involves numerous parameters, including the requirements to obtain a patent,
the scope of proprietary rights, and the term of protection. In theory these attributes could be
tailored to meet the needs of different sectors. Defining industry-specific or technology-specific
patent doctrines presents some practical difficulties, however, and may also give rise to
incompatibilities with the WTO TRIPS Agreement.
Should Congress consider current circumstances with respect to the patent system to be
appropriate, then no action need be taken. However, should Congress believe that different
sectors possess distinctive needs with respect to the patent system, a number of options exist. As
noted, the TRIPS Agreement provides for a number of limited exceptions to the general rule of
technological neutrality. U.S. legislation could simply track the exceptions identified by the
provisions of the TRIPS Agreement, with particular reference to their interpretation by WTO
dispute resolution panels.
97 Ibid.
98 Wesley A. Cann, Jr., “On the Relationship Between Intellectual Property Rights and the Need of Less-Developed
Countries for Access to Pharmaceuticals: Creating a Legal Duty to Supply Under a Theory of Progressive Global
Constitutionalism,” 25 University of Pennsylvania Journal of International Economic Law (2004), 755.
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Congress could also potentially draw distinctions among grounds not identified by Article 27.1 of
the TRIPS Agreement—namely, the place of invention, the field of technology, and whether
products are imported or produced locally. For example, the Leahy-Smith America Invents Act
(AIA) established an infringement defense based upon the prior commercial use of the patented
invention by the accused infringer.99 The AIA stipulated that this defense was unavailable if the
patented invention was made by an institution of higher education, however.100 This “university
exception” appears to comply with the TRIPS Agreement because it draws a distinction based
upon the identity of the inventor, rather than on a ground identified in Article 27.1.
Another option is the establishment of additional intellectual property rights that complement
patents. For example, Congress has established so-called “regulatory exclusivities,” a term that
refers to a period of time during which a regulated product is afforded protection from competing
applications for marketing approval.101 Most notably, the food and drug laws establish a number
of regulatory exclusivities that apply to pharmaceuticals and are administered by the Food and
Drug Administration. In contrast to patents, regulatory exclusivities are not subject to extensive
regulation by the TRIPS Agreement.102 As a result, at least with respect to regulated industries,
regulatory exclusivities may provide a more flexible instrument for legislative tailoring of
intellectual property rights.103
Whether legal doctrines should be expressed as discrete rules or more generally phrased standards
is a long-standing debate within the field of jurisprudence.104 Placed within the context of
congressional consideration of our intellectual property laws, the debate suggests that distinct
rules for different sectors form one possibility for patent reform. Yet Congress may also craft
broader principles that may be appropriately applied across the diverse industries and
technologies to which the patent system pertains. Determining whether a rule or a standard
provides the most appropriate vehicle for a particular reform to our patent laws remains a matter
of legislative judgment.
Author Contact Information
John R. Thomas
Visiting Scholar
jrthomas@crs.loc.gov, 7-0975
99 P.L. 112-29, 125 Stat. 284 (2011), at § 5.
100 Ibid. (establishing 35 U.S.C. § 273(e)(5)).
101 See Yaniv Heled, “Patents vs. Statutory Exclusivities in Biological Pharmaceuticals—Do We Really Need Both?,”
18 Michigan Telecommunications & Technology Law Review (2012), 419.
102 See Christina Bucci, “Responsible Patent Protections: Preserving Public Health Objectives in the Trans-Pacific
Partnership Agreement,” 26 Pacific McGeorge Global Business & Development Law Journal (2013), 213.
103 See Eisenberg, supra.
104 See David Olson & Stefania Fusco, “Rules Versus Standards: Competing Notions of Inconsistency Robustness in
Patent Law,” 64 Alabama Law Review (2013), 647.
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